EP3888577A1 - One piece sternum replacement implant - Google Patents

One piece sternum replacement implant Download PDF

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Publication number
EP3888577A1
EP3888577A1 EP20000231.9A EP20000231A EP3888577A1 EP 3888577 A1 EP3888577 A1 EP 3888577A1 EP 20000231 A EP20000231 A EP 20000231A EP 3888577 A1 EP3888577 A1 EP 3888577A1
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EP
European Patent Office
Prior art keywords
sternum
implant
extensions
fitting
manufactured
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP20000231.9A
Other languages
German (de)
French (fr)
Inventor
Mauricio TORO RESTREPO
Juan Pablo Martínez Carett
Daniel Restrepo Mejía
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Techfit Digital Surgery Inc
Original Assignee
Techfit Digital Surgery Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Techfit Digital Surgery Inc filed Critical Techfit Digital Surgery Inc
Publication of EP3888577A1 publication Critical patent/EP3888577A1/en
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8061—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
    • A61B17/8076—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones for the ribs or the sternum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/82—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage
    • A61B17/823—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage for the sternum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B2017/568—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor produced with shape and dimensions specific for an individual patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/108—Computer aided selection or customisation of medical implants or cutting guides

Definitions

  • the present invention relates to the field of biomedical engineering, particularly relates to an implant for sternum replacement comprising an upper face, a posterior face, extensions for fitting with the ribs and extensions for fitting with the manubrium, wherein that implant is manufactured in a single piece with high performance engineering polymers, with an anatomical adjustment tailored to each patient, which guarantees the reduction of the number of elements in contact with the patient, facilitating and speeding up the surgical procedure and, at the same time, providing the necessary mechanical and flexibility properties.
  • sternotomy In some cases of infection, accidents, heart surgeries or the presence of cancer tumors, it is necessary to practice a total sternotomy, that is, the extraction of the sternum bone, which is a flat, odd, central and symmetrical (usually) chest bone, consisting of several welded parts.
  • the sternum helps protect the heart and lungs.
  • the mediastinum At the back of it is the mediastinum, which includes the extrapleural anatomical complement located in the center of the chest, between the left and right lungs.
  • the invention defined herein has the disadvantage that it is not custom made for the patient, at the same time it does not show an implant developed in high performance engineering polymers.
  • CN109077831A provides a type of prosthetic sternum devices, which includes a sternal part; multiple rib cage portions located on the sternal side. The interior of one or more portions of the rib cage is disposed in the prosthetic fusion portion.
  • said prosthetic fusion portion allows growth during the rib cage portion with the bone fusion to grow integrally, eventually grow to a relatively stable level and biologically active support construction, while this support construction may also cause stimulation transported to the peripheral blood, promoting the repair of damaged cartilage.
  • the invention defined herein has the disadvantage that it is not custom made for the patient, at the same time it does not show an implant developed in high performance engineering polymers.
  • WO / 2018/132179 presents an implant for a human sternum and ribs that includes a sternal implant and a rib link.
  • the sternal implant can be attached to the sternum.
  • the rib bond may include a distal portion, a proximal portion, and a strut.
  • the distal portion can be attachable to a rib.
  • the proximal portion may be attachable to the sternal implant.
  • the strut can connect the distal portion to the proximal portion.
  • the strut can be configured to flex so that the distal portion can align with the rib.
  • the invention defined herein has the disadvantage that it is not custom made for the patient in a single piece, at the same time it does not show an implant developed in high performance engineering polymers.
  • CN209136987U discloses a type of artificial sternum bone made of carbon / carbon composite material, including the main body of the sternum, and the integral structure of the branch is connected to the rib cage, and the connecting branch of the rib cage is distributed in the sternum on two sides.
  • the artificial sternum bone has three layers, and the intermediate layer is a base layer of carbon / carbon composite material, and the upper epidermis is a coating High porosity carbon, and the layer is a pyrocarbon coating, a silicon carbide layer, or a pyrolytic carbon / silicon carbide mixed layer.
  • Artificial sternum bone has many advantages, such as that light weight, specific resistance is high, histocompatibility is good, easy to use.
  • the invention defined herein has the disadvantage that it is not custom made for the patient, at the same time it does not show an implant developed in high performance engineering polymers.
  • Document FR3032876A1 refers particularly to an implant for sternal closure after a sternotomy that is comprised of a central block comprised of a superior and an inferior face that comprises a first module and a second module.
  • This first module is meant to be attached to one part of the sternum and has a medial face that is meant to be positions right in front of the medial side of the second module that is located in the other part of the sternum.
  • Said implant has at least one means to join the two medial faces of the modules and at least one means of blocking the removable device that goes through at least one of the modules.
  • Said means of blocking is accesible from the frontal side of the implant.
  • the invention defined herein has the disadvantage that it is not custom made for the patient in a single piece.
  • those implants have properties of high resistance, light weight, biocompatibility, and that allow avoiding the risk of infections, facilitating and expediting surgical interventions.
  • the present invention is directed to an implant for sternum replacement, which is composed of the following components: Sternum implant (1) comprising an upper face (11), a posterior face (12), extensions for coupling with the ribs (2), extensions for coupling with the manubrium(3), wherein that implant is made from high performance engineering polymers, such as PEEK, PEKK or carbon fiber reinforced PEEK, where those fibers are continuous or discontinuous, in order to guarantee the necessary mechanical properties, at the same time as they are biocompatible, lightweight and highly resistant and flexible which facilitates the reduction of the number of pieces necessary for the intervention, also reducing the risk of infection.
  • Sternum implant comprising an upper face (11), a posterior face (12), extensions for coupling with the ribs (2), extensions for coupling with the manubrium(3), wherein that implant is made from high performance engineering polymers, such as PEEK, PEKK or carbon fiber reinforced PEEK, where those fibers are continuous or discontinuous, in order to guarantee the necessary mechanical properties, at the same time as they are biocompatible, lightweight and highly resistant
  • This implant is manufactured in a single piece by machining, in accordance with CAD / CAM techniques and computer-assisted surgical planning, in order to adjust to the anatomy of each patient, specifically, the geometry of that posterior face fits anatomically with the mediastinum, the geometry of those fitting extensions with the ribs is anatomically adjusted with the ribs, the geometry of those fitting extensions with the manubrium is anatomically adjusted with the manubrium.
  • This implant is fixed to the patient's body, by direct fixation or through holes where titanium or steel screws are placed, or with titanium and steel plates.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Prostheses (AREA)

Abstract

The present invention relates to an implant for sternum replacement comprising an upper face, a posterior face, extensions for fitting with the ribs and extensions for fitting with the manubrium, wherein that implant is manufactured in a single piece with high performance engineering polymers, with an anatomical adjustment tailored to each patient, which guarantees the reduction of the number of elements in contact with the patient, facilitating and speeding up the surgical procedure, at the same time, the required mechanical and flexibility properties, are guaranteed.

Description

    Technical field
  • The present invention relates to the field of biomedical engineering, particularly relates to an implant for sternum replacement comprising an upper face, a posterior face, extensions for fitting with the ribs and extensions for fitting with the manubrium, wherein that implant is manufactured in a single piece with high performance engineering polymers, with an anatomical adjustment tailored to each patient, which guarantees the reduction of the number of elements in contact with the patient, facilitating and speeding up the surgical procedure and, at the same time, providing the necessary mechanical and flexibility properties.
    • Background of the invention
  • In some cases of infection, accidents, heart surgeries or the presence of cancer tumors, it is necessary to practice a total sternotomy, that is, the extraction of the sternum bone, which is a flat, odd, central and symmetrical (usually) chest bone, consisting of several welded parts. The sternum helps protect the heart and lungs. At the back of it is the mediastinum, which includes the extrapleural anatomical complement located in the center of the chest, between the left and right lungs.
  • To replace the sternum, a series of implants made with different materials have been used, among which the titanium metal plates, ceramic alumina plates, and in some cases in which the sternum is not completely replaced, high performance engineering polymers. However, normally this type of implant meets standard geometries and requires a large number of additional elements for fixation and complementary elements to guarantee the correct performance of the implant, hindering the surgical process and increasing the risk of infections and complications.
  • Thus, in the state of the art there are a plurality of disclosures related to implants or plates for total or partial sternum replacement, with different geometries and materials, among which is the document US2018177914 , refers to an implant for sternum replacement comprising an alumina ceramic, where the alumina ceramic has a volume porosity of 45 to 75% and a pore size of 200 to 600 µm.
  • However, the invention defined herein has the disadvantage that it is not custom made for the patient, at the same time it does not show an implant developed in high performance engineering polymers.
  • On the other hand, there is also document CN109077831A , in which provides a type of prosthetic sternum devices, which includes a sternal part; multiple rib cage portions located on the sternal side. The interior of one or more portions of the rib cage is disposed in the prosthetic fusion portion. Wherein said prosthetic fusion portion allows growth during the rib cage portion with the bone fusion to grow integrally, eventually grow to a relatively stable level and biologically active support construction, while this support construction may also cause stimulation transported to the peripheral blood, promoting the repair of damaged cartilage.
  • However, the invention defined herein has the disadvantage that it is not custom made for the patient, at the same time it does not show an implant developed in high performance engineering polymers.
  • In the state of the art, there is also document WO / 2018/132179 , which presents an implant for a human sternum and ribs that includes a sternal implant and a rib link. The sternal implant can be attached to the sternum. The rib bond may include a distal portion, a proximal portion, and a strut. The distal portion can be attachable to a rib. The proximal portion may be attachable to the sternal implant. The strut can connect the distal portion to the proximal portion. The strut can be configured to flex so that the distal portion can align with the rib.
  • However, the invention defined herein has the disadvantage that it is not custom made for the patient in a single piece, at the same time it does not show an implant developed in high performance engineering polymers.
  • On the other hand, have document CN209136987U , which discloses a type of artificial sternum bone made of carbon / carbon composite material, including the main body of the sternum, and the integral structure of the branch is connected to the rib cage, and the connecting branch of the rib cage is distributed in the sternum on two sides. The artificial sternum bone has three layers, and the intermediate layer is a base layer of carbon / carbon composite material, and the upper epidermis is a coating High porosity carbon, and the layer is a pyrocarbon coating, a silicon carbide layer, or a pyrolytic carbon / silicon carbide mixed layer. Artificial sternum bone has many advantages, such as that light weight, specific resistance is high, histocompatibility is good, easy to use.
  • However, the invention defined herein has the disadvantage that it is not custom made for the patient, at the same time it does not show an implant developed in high performance engineering polymers.
  • Finally, Document FR3032876A1 refers particularly to an implant for sternal closure after a sternotomy that is comprised of a central block comprised of a superior and an inferior face that comprises a first module and a second module. This first module is meant to be attached to one part of the sternum and has a medial face that is meant to be positions right in front of the medial side of the second module that is located in the other part of the sternum. Said implant has at least one means to join the two medial faces of the modules and at least one means of blocking the removable device that goes through at least one of the modules. Said means of blocking is accesible from the frontal side of the implant.
  • However, the invention defined herein has the disadvantage that it is not custom made for the patient in a single piece.
  • In accordance with the previous statements, it is clear that in the state of the art there is a need to design an implant for sternum replacement tailored to the patient, which has a geometry that adjusts to the ribs, the mediastinum and the manubrium, that is developed in a single piece in a material that guarantees flexibility for its correct operation.
  • Additionally, it is necessary that those implants have properties of high resistance, light weight, biocompatibility, and that allow avoiding the risk of infections, facilitating and expediting surgical interventions.
    • Brief description of the figures
  • The present invention is understood more clearly from the following figures where the components and results associated with the present development are shown, as well as the novel features with respect to the state of the art, where the figures are not intended to limit the scope of the invention, which is only given by the appended claims, wherein:
    • Figure 1 corresponds to a front view of the implant for sternum replacement.
    • Figure 2 corresponds to a posterior view of the implant for sternum replacement.
    Detailed description of the invention
  • The present invention is directed to an implant for sternum replacement, which is composed of the following components:
    Sternum implant (1) comprising an upper face (11), a posterior face (12), extensions for coupling with the ribs (2), extensions for coupling with the manubrium(3), wherein that implant is made from high performance engineering polymers, such as PEEK, PEKK or carbon fiber reinforced PEEK, where those fibers are continuous or discontinuous, in order to guarantee the necessary mechanical properties, at the same time as they are biocompatible, lightweight and highly resistant and flexible which facilitates the reduction of the number of pieces necessary for the intervention, also reducing the risk of infection.
  • This implant is manufactured in a single piece by machining, in accordance with CAD / CAM techniques and computer-assisted surgical planning, in order to adjust to the anatomy of each patient, specifically, the geometry of that posterior face fits anatomically with the mediastinum, the geometry of those fitting extensions with the ribs is anatomically adjusted with the ribs, the geometry of those fitting extensions with the manubrium is anatomically adjusted with the manubrium.
  • This implant is fixed to the patient's body, by direct fixation or through holes where titanium or steel screws are placed, or with titanium and steel plates.
  • Although the previous description defines the preferred embodiments of the present invention, this invention is not limited to these, but, on the contrary, it is also intended to include within the scope of the present application all the variations or modifications that are evident for the experts in the field and that do not affect and change the spirit of the invention.

Claims (8)

  1. Sternum implant (1) characterized because it comprises an upper face (11), a posterior face (12), extensions for fitting with the ribs (2), extensions for fitting with the manubrium (3), where this implant is manufactured with engineering polymers.
  2. The sternum implant of claim 1 characterized in that it is a sternum replacement implant.
  3. The sternum implant of claim 1 characterized in that it is manufactured in a single piece.
  4. The sternum implant according to any of the preceding claims, characterized in that, the geometry of that posterior face fits anatomically with the mediastinum, the geometry of those fitting extensions with the ribs are anatomically adjusted with the ribs, the geometry of those fitting extensions with the manubrium is anatomically adjusted with the manubrium.
  5. The sternum implant according to any of the preceding claims, characterized in that it is manufactured with engineering polymers such as PEEK, PEKK or PEEK or Carbon Fiber reinforced PEEK, where those fibers are continuous or discontinuous.
  6. The sternum implant according to any of the previous claims, characterized in that, it is custom developed for the patient with CAD / CAM techniques and computer-assisted surgical planning.
  7. The sternum implant according to any of the preceding claims, characterized in that it is manufactured by machining or additive manufacturing.
  8. The sternum implant according to any of the preceding claims, characterized in that it is fixed with screws.
EP20000231.9A 2020-03-30 2020-06-29 One piece sternum replacement implant Withdrawn EP3888577A1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CONC2020/0003879A CO2020003879A1 (en) 2020-03-30 2020-03-30 One-piece sternum replacement implant

Publications (1)

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EP3888577A1 true EP3888577A1 (en) 2021-10-06

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EP20000231.9A Withdrawn EP3888577A1 (en) 2020-03-30 2020-06-29 One piece sternum replacement implant

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EP (1) EP3888577A1 (en)
CO (1) CO2020003879A1 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4014639A1 (en) * 2019-08-16 2022-06-22 Telefonaktiebolaget Lm Ericsson (Publ) Overlapping transmission in urllc
DE102021211157A1 (en) 2021-10-04 2023-04-06 Karl Leibinger Medizintechnik Gmbh & Co. Kg implant system

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140371897A1 (en) * 2013-06-14 2014-12-18 Osiris Biomed 3D, Llc Co-located scanning, printing and/or machining devices for medical constructs
FR3032876A1 (en) 2015-02-24 2016-08-26 Bertrand Perrin IMPLANT OF INTRA-MEDALLIONAL STERNUM
US20180177914A1 (en) 2015-06-23 2018-06-28 I.Ceram Sternum replacement implant
US20180193073A1 (en) * 2017-01-11 2018-07-12 Zimmer Biomet CMF and Thoracic, LLC Adjustable rib and sternal implant
CN109077831A (en) 2018-10-23 2018-12-25 北京爱康宜诚医疗器材有限公司 Breastbone prosthetic appliance
CN209136987U (en) 2017-08-23 2019-07-23 湖南碳康生物科技有限公司 A kind of carbon/carbon compound material artificial sternum skeleton

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Publication number Priority date Publication date Assignee Title
US9597132B2 (en) * 2013-01-12 2017-03-21 Louis Houff Sternum fixation device and method
ES2748777T3 (en) * 2015-02-24 2020-03-17 Neuro France Implants Prosthetic sternum device with handlebar
CA2969998A1 (en) * 2016-06-17 2017-12-17 Socovar, L.P. Limb sparing in mammals using patient-specific endoprostheses and cutting guides
AU2017296286B9 (en) * 2016-07-11 2021-07-29 Revelation Plating, Llc Chest wall repair device
CO2017008458A1 (en) * 2017-08-21 2017-08-31 Conalmedicas S A S Prosthetic device for reconstruction of the sternum, ribs and clavicles
US12089882B2 (en) * 2019-04-30 2024-09-17 Fusion Innovations, Llc Method and system for assembling a structure to secure to opposite sides of a fracture in a bone of a subject
DE102019111978B4 (en) * 2019-05-08 2022-06-09 Instituto Tecnológico De Canarias, S.A. Prosthesis for the reconstruction of connective and supporting tissue in particular

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140371897A1 (en) * 2013-06-14 2014-12-18 Osiris Biomed 3D, Llc Co-located scanning, printing and/or machining devices for medical constructs
FR3032876A1 (en) 2015-02-24 2016-08-26 Bertrand Perrin IMPLANT OF INTRA-MEDALLIONAL STERNUM
US20180177914A1 (en) 2015-06-23 2018-06-28 I.Ceram Sternum replacement implant
US20180193073A1 (en) * 2017-01-11 2018-07-12 Zimmer Biomet CMF and Thoracic, LLC Adjustable rib and sternal implant
WO2018132179A1 (en) 2017-01-11 2018-07-19 Zimmer Biomet CMF and Thoracic, LLC Adjustable rib and sternal implant
CN209136987U (en) 2017-08-23 2019-07-23 湖南碳康生物科技有限公司 A kind of carbon/carbon compound material artificial sternum skeleton
CN109077831A (en) 2018-10-23 2018-12-25 北京爱康宜诚医疗器材有限公司 Breastbone prosthetic appliance

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US11510714B2 (en) 2022-11-29
CO2020003879A1 (en) 2021-04-08
US20210298808A1 (en) 2021-09-30

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